Spinal surgery system and methods of use

ABSTRACT

A method for surgically treating a spine comprising the steps of: pre-operatively imaging vertebral tissue; displaying a first image of a surgical treatment configuration for the vertebral tissue from a mixed reality display and/or a second image of a surgical strategy for implementing the surgical treatment configuration with the vertebral tissue from the mixed reality display; determining a surgical plan for implementing the surgical strategy; and intra-operatively displaying a third image of the surgical plan with the vertebral tissue from the mixed reality display. Systems, spinal constructs, implants and surgical instruments are disclosed.

TECHNICAL FIELD

The present disclosure generally relates to medical systems for thetreatment of musculoskeletal disorders, and more particularly to asurgical system and method for treating a spine.

BACKGROUND

Spinal disorders such as degenerative disc disease, disc herniation,osteoporosis, spondylolisthesis, stenosis, scoliosis and other curvatureabnormalities, kyphosis, tumor and fracture may result from factorsincluding trauma, disease and degenerative conditions caused by injuryand aging. Spinal disorders typically result in symptoms including pain,nerve damage, and partial or complete loss of mobility.

Non-surgical treatments, such as medication, rehabilitation and exercisecan be effective, however, may fail to relieve the symptoms associatedwith these disorders. Surgical treatment of these spinal disordersincludes correction, fusion, fixation, discectomy, laminectomy andimplantable prosthetics. As part of these surgical treatments, interbodydevices can be employed with spinal constructs, which include implantssuch as bone fasteners and vertebral rods to provide stability to atreated region. These implants can redirect stresses away from a damagedor defective region while healing takes place to restore properalignment and generally support the vertebral members. During surgicaltreatment, surgical systems including surgical navigation and/orsurgical instruments are employed, for example, to facilitate surgicalpreparation, manipulation of tissue and delivering implants to asurgical site. This disclosure describes an improvement over these priortechnologies.

SUMMARY

In one embodiment, a method for surgically treating a spine is provided.The method comprises the steps of: pre-operatively imaging vertebraltissue; displaying a first image of a surgical treatment configurationfor the vertebral tissue from a mixed reality display and/or a secondimage of a surgical strategy for implementing the surgical treatmentconfiguration with the vertebral tissue from the mixed reality display;determining a surgical plan for implementing the surgical strategy; andintra-operatively displaying a third image of the surgical plan with thevertebral tissue from the mixed reality display. In some embodiments,systems, spinal constructs, implants and surgical instruments aredisclosed.

In one embodiment, the method comprises the steps of: pre-operativelyimaging vertebral tissue; displaying a first image of a segmentation anda surgical reconstruction of the vertebral tissue from a holographicdisplay and/or a second image of a surgical strategy that includes oneor more spinal implants with the vertebral tissue from the holographicdisplay; determining a surgical plan for implementing the surgicalstrategy; and intra-operatively displaying a third image of the surgicalplan with the vertebral tissue from the holographic display.

In one embodiment, the method comprises the steps of: pre-operativelyimaging vertebral tissue; transmitting data points of the imaging to acomputer database and determining a surgical treatment configuration forthe vertebral tissue; determining a surgical strategy for implementingthe surgical treatment configuration; generating data pointsrepresentative of a first image of the surgical treatment configurationand a second image of the surgical strategy; displaying the first imageand/or the second image from a mixed reality display; determining asurgical plan for implementing the surgical strategy with the vertebraltissue and generating data points representative of a third image of thesurgical plan; displaying the third image with the vertebral tissue fromthe mixed reality display; imaging surgically treated vertebral tissue;generating data points representative of a fourth image comparing thethird image and the imaging of the surgically treated vertebral tissue;and displaying the fourth image from the mixed reality display.

BRIEF DESCRIPTION OF THE DRAWINGS

The present disclosure will become more readily apparent from thespecific description accompanied by the following drawings, in which:

FIG. 1 is a perspective view of components of one embodiment of asurgical system in accordance with the principles of the presentdisclosure;

FIG. 2 is a perspective view of components of the surgical system shownin FIG. 1 ;

FIG. 3 is a perspective view of components of one embodiment of asurgical system including a representation of imaging of vertebrae inaccordance with the principles of the present disclosure;

FIG. 4 is a flow diagram illustrating representative steps of one ormore embodiments of a method and a surgical system in accordance withthe principles of the present disclosure;

FIG. 5 is a flow diagram illustrating representative steps of one ormore embodiments of a method and a surgical system in accordance withthe principles of the present disclosure;

FIG. 6 is a schematic diagram illustrating components of one embodimentof a surgical system including a representation of imaging and steps ofa method in accordance with the principles of the present disclosure;

FIG. 7 is a schematic diagram illustrating components of one embodimentof a surgical system and representative steps of embodiments of a methodin accordance with the principles of the present disclosure;

FIG. 8 is a schematic diagram illustrating components of one embodimentof a surgical system including a representation of imaging and steps ofa method in accordance with the principles of the present disclosure;

FIG. 9 is a perspective view of components of one embodiment of asurgical system including a representation of imaging of vertebrae inaccordance with the principles of the present disclosure;

FIG. 10 is a schematic diagram illustrating components of one embodimentof a surgical system including a representation of imaging and steps ofa method in accordance with the principles of the present disclosure;

FIG. 11 is a schematic diagram illustrating components of one embodimentof a surgical system including a representation of imaging and steps ofa method in accordance with the principles of the present disclosure;

FIG. 12 is a flow diagram illustrating representative steps of one ormore embodiments of a method and a surgical system in accordance withthe principles of the present disclosure;

FIG. 13 is a flow diagram illustrating representative steps of one ormore embodiments of a method and a surgical system in accordance withthe principles of the present disclosure; and

FIG. 14 is a flow diagram illustrating representative steps of one ormore embodiments of a method and a surgical system in accordance withthe principles of the present disclosure.

DETAILED DESCRIPTION

The exemplary embodiments of a surgical system are discussed in terms ofmedical devices for the treatment of musculoskeletal disorders and moreparticularly, in terms of a surgical system and a method for treating aspine. In some embodiments, the present surgical system includes a mixedreality display or an augmented reality display, and is employed with amethod for surgically treating a spine including surgical planning,performing a surgical procedure, intra-operative correction and/orreconciling the performed surgical procedure with the surgical plan. Insome embodiments, the present surgical system comprises a displayincluding a holographic display device. In some embodiments, the systemsand methods of the present disclosure comprise a mixed reality displayor an augmented reality display, surgical robotic guidance, surgicalnavigation and medical devices including surgical instruments andimplants that are employed with a surgical treatment, as describedherein, for example, with a cervical, thoracic, lumbar and/or sacralregion of a spine.

In some embodiments, the present surgical system includes pre-operativeimaging of a patient's vertebrae, for example, through 3D imaginggenerated from a CT scan. In some embodiments, a computer converts thepre-operative imaging to digital data and transfers the digital data toa mixed reality headset, for example, a holographic headset. In someembodiments, the computer utilizes software to determine segmentationand/or reconstruction of the vertebrae and/or mixed reality/holographicsurgical planning that is uploaded to the headset for display from theheadset. In some embodiments, the data is transferred to a roboticguidance system and/or surgical navigation system. In some embodiments,the robotic guidance system and/or surgical navigation system includesregistered navigation data on actual vertebrae/body coordinates andsurgical instruments that are used for the surgical procedure based onemitter arrays that are attached to the surgical instruments and areanchored to a body reference position, for example, a patient's pelvis.In some embodiments, the navigation data is transferred to the headsetand/or the computer. In some embodiments, the previously determinedsurgical plan is holographically overlaid onto the actual patient,including, for example, the patient's vertebrae and/or a surface of thebody during the surgical procedure. In some embodiments, intra-operativeor post-operative imaging is taken, for example, through 3D imaginggenerated from a CT scan. In some embodiments, the computer converts theintra-operative or post-operative imaging to digital data and transfersthe digital data to the headset for reconciliation of the surgical plan.

In some embodiments, the present surgical system includes a holographicdisplay system that is implemented in an operating room during asurgical procedure such that digital surgical plans are integrated witha patient for procedure execution and reconciliation. In someembodiments, the digital surgical plans are integrated with the patientthrough a holographic overlay. In some embodiments, the holographicoverlay includes a digital surgical plan that is patient specific. Insome embodiments, the digital surgical plan utilizes patient specificanatomy data generated from pre-operative images, for example, computedtomography (CT) scans In some embodiments, the holographic overlay issuperimposed on a surface of the patient in the operating room during asurgical procedure and implemented as a guide for correction of thesurgical procedure.

In some embodiments, the present surgical system includes recognitionmarkers positioned relative to the patient to map the surface of thepatient. In some embodiments, a scanner is implemented to map thesurface of the patient. In some embodiments, the holographic overlay isimplemented in conjunction with a camera and/or sensors to measurephysical corrections during the surgical procedure so that the surgicalplan can be reconciled.

In some embodiments, the present surgical system and methods includespatially located three dimensional (3D) holograms, for example,holographic overlays for displaying image guidance information. In someembodiments, the present surgical system and methods include cameras,for example, depth sensing cameras. In some embodiments, the depthsensing cameras include infrared, laser, and/or red/green/blue (RGB)cameras. In some embodiments, depth sensing cameras along withsimultaneous localization and mapping are employed to digitize thepatient, spinal anatomy, and/or the operating room for spatiallylocating holograms and then displaying the digital information. In someembodiments, the present surgical system and methods include softwarealgorithms, for example, object recognition software algorithms that areimplemented for spatially locating the holograms and for displayingdigital information. In some embodiments, machine learning algorithmsare employed that identify patient anatomical features, instrumentfeatures and/or implant features for spatially locating holograms anddisplaying digital information. In some embodiments, software algorithmsare implemented in 3D image processing software employed for theprocedure planning including for example, software algorithms forimporting, thresholding, masking, segmentation, cropping, clipping,panning, zooming, rotating, measuring and/or registering.

In some embodiments, the present surgical system and methods includedepth sensing cameras, for example, infrared, laser, and/or RGB cameras;spatial transducers, for example, electromagnetic, low energyBluetooth®, and/or inertial measurement units; optical markers, forexample, reflective spheres, QR codes/patterns, and/or fiducials; and/orobject recognition software algorithms to track a spatial position of apatient, for example, a patient's vertebral bodies and update a digitalrepresentation in real time. In some embodiments, the present surgicalsystem and methods include 3D imaging software algorithms implemented torender and display changes in an anatomical position in real-time. Insome embodiments, the present surgical system and methods includeholographic display technology, for example, optical waveguides todisplay holograms, image guidance, and/or other digital information inreal-time.

In some embodiments, the present surgical system and methods includeimage guidance and pre-operative software planning tools to defineanatomic regions of interest in a patient and danger zones or areas toavoid during surgery for a controlled guidance of tools within definedzones during the procedure. In some embodiments, the present surgicalsystem and methods include depth sensing cameras used simultaneouslywith localization and mapping to map bone surfaces of a patient duringthe procedure for use in defining regions of interest and avoidance withimage guidance.

In some embodiments, the present surgical system is employed withmethods for spinal surgical procedure planning and reconciliation. Insome embodiments, the present surgical system is employed with methodsincluding the step of pre-operatively imaging a section of a patient'sspine. In some embodiments, the present surgical system is employed withmethods including the step of converting the pre-operative imaging intodigital data. In some embodiments, the present surgical system isemployed with methods including the step of transferring the data to aholographic display system. In some embodiments, the holographic displaysystem includes a processor, a graphics processing unit (GPU), andsoftware for auto-segmentation and planning. In some embodiments, thepresent surgical system is employed with methods including the step ofoverlaying the pre-operative data with a holographic surgical plan. Insome embodiments, the present surgical system is employed with methodsincluding the step of transferring the holographic surgical plan data toan image guidance or robotic surgical system. In some embodiments, thepresent surgical system is employed with methods including the step ofviewing the holographic overlay superimposed on a patient for procedureexecution. In some embodiments, the viewing is performed through a headmounted display for example, goggles or glasses, a tablet, a smartphone,a contact lens and/or an eye loop. In some embodiments, the presentsurgical system is employed with methods including the step ofperforming the surgical procedure. In some embodiments, the presentsurgical system is employed with methods including the step ofintra-operatively and/or post-operatively imaging a section of thespine. In some embodiments, the present surgical system is employed withmethods including the step of converting the intra-operative and/orpost-operative imaging into data. In some embodiments, the presentsurgical system is employed with methods including the step oftransferring the data to the holographic display system. In someembodiments, the present surgical system is employed with methodsincluding the step of comparing the surgical plan with an outcome of thesurgical procedure. In some embodiments, the present surgical system isemployed with methods including the step of reconciling the surgicaloutcome with the surgical plan.

In some embodiments, the present surgical system and methods include asurgical plan holographic overlay and/or software that indicates and/oralerts a user, for example, a surgeon, of danger zones located on ananatomy of a patient to assist the surgeon in planning a surgicalprocedure. In some embodiments, the surgical plan holographic overlayand/or the software generates a warning to the surgeon if a surgicalinstrument, for example, a drill or a screw is about to enter into adanger zone or a dangerous area. In some embodiments, the presentsurgical system and methods include a surgical plan holographic overlayand/or software that enables a surgeon to select specific locations, forexample, critical bone faces on anatomical areas of a patient such thatan alarm or a warning is generated when the specific locations are indanger of being breached. In some embodiments, the surgical system isconfigured to auto-recognize the specific locations. In someembodiments, the present surgical system and methods include aholographic overlay of an optimized corrected spine that is configuredfor superimposing over a surface of a patient such that the holographicoverlay is implemented as a guide for the surgeon during spinalcorrection.

In some embodiments, the system of the present disclosure may beemployed to treat spinal disorders such as, for example, degenerativedisc disease, disc herniation, osteoporosis, spondylolisthesis,stenosis, scoliosis and other curvature abnormalities, kyphosis, tumorand fractures. In some embodiments, the system of the present disclosuremay be employed with other osteal and bone related applications,including those associated with diagnostics and therapeutics. In someembodiments, the disclosed system may be alternatively employed in asurgical treatment with a patient in a prone or supine position, and/oremploy various surgical approaches to the spine, including anterior,posterior, posterior mid-line, direct lateral, postero-lateral, and/orantero-lateral approaches, and in other body regions. The system of thepresent disclosure may also be alternatively employed with proceduresfor treating the lumbar, cervical, thoracic, sacral and pelvic regionsof a spinal column. The system of the present disclosure may also beused on animals, bone models and other non-living substrates, such as,for example, in training, testing and demonstration.

The system of the present disclosure may be understood more readily byreference to the following detailed description of the embodiments takenin connection with the accompanying drawing figures, which form a partof this disclosure. It is to be understood that this application is notlimited to the specific devices, methods, conditions or parametersdescribed and/or shown herein, and that the terminology used herein isfor the purpose of describing particular embodiments by way of exampleonly and is not intended to be limiting. In some embodiments, as used inthe specification and including the appended claims, the singular forms“a,” “an,” and “the” include the plural, and reference to a particularnumerical value includes at least that particular value, unless thecontext clearly dictates otherwise. Ranges may be expressed herein asfrom “about” or “approximately” one particular value and/or to “about”or “approximately” another particular value. When such a range isexpressed, another embodiment includes from the one particular valueand/or to the other particular value. Similarly, when values areexpressed as approximations, by use of the antecedent “about,” it willbe understood that the particular value forms another embodiment. It isalso understood that all spatial references, such as, for example,horizontal, vertical, top, upper, lower, bottom, left and right, are forillustrative purposes only and can be varied within the scope of thedisclosure. For example, the references “upper” and “lower” are relativeand used only in the context to the other, and are not necessarily“superior” and “inferior”.

As used in the specification and including the appended claims,“treating” or “treatment” of a disease or condition refers to performinga procedure that may include administering one or more drugs to apatient (human, normal or otherwise or other mammal), employingimplantable devices, and/or employing instruments that treat thedisease, such as, for example, microdiscectomy instruments used toremove portions bulging or herniated discs and/or bone spurs, in aneffort to alleviate signs or symptoms of the disease or condition.Alleviation can occur prior to signs or symptoms of the disease orcondition appearing, as well as after their appearance. Thus, treatingor treatment includes preventing or prevention of disease or undesirablecondition (e.g., preventing the disease from occurring in a patient, whomay be predisposed to the disease but has not yet been diagnosed ashaving it). In addition, treating or treatment does not require completealleviation of signs or symptoms, does not require a cure, andspecifically includes procedures that have only a marginal effect on thepatient. Treatment can include inhibiting the disease, e.g., arrestingits development, or relieving the disease, e.g., causing regression ofthe disease. For example, treatment can include reducing acute orchronic inflammation; alleviating pain and mitigating and inducingre-growth of new ligament, bone and other tissues; as an adjunct insurgery; and/or any repair procedure. Also, as used in the specificationand including the appended claims, the term “tissue” includes softtissue, ligaments, tendons, cartilage and/or bone unless specificallyreferred to otherwise.

The following discussion includes a description of a surgical systemincluding mixed and/or augmented reality technology, holographicoverlays, surgical navigation, surgical robotic guidance, surgicalinstruments, spinal constructs, implants, related components and methodsof employing the surgical system in accordance with the principles ofthe present disclosure. Alternate embodiments are also disclosed.Reference is made in detail to the exemplary embodiments of the presentdisclosure, which are illustrated in the accompanying figures. Turningto FIGS. 1-11 , there are illustrated components of a surgical system10.

The components of surgical system 10 can be fabricated from biologicallyacceptable materials suitable for medical applications, includingmetals, synthetic polymers, ceramics and bone material and/or theircomposites. For example, the components of surgical system 10,individually or collectively, can be fabricated from materials such asstainless steel alloys, aluminum, commercially pure titanium, titaniumalloys, Grade 5 titanium, super-elastic titanium alloys, cobalt-chromealloys, superelastic metallic alloys (e.g., Nitinol, superelasto-plastic metals, such as GUM METAL®), ceramics and compositesthereof such as calcium phosphate (e.g., SKELITE™), thermoplastics suchas polyaryletherketone (PAEK) including polyetheretherketone (PEEK),polyetherketoneketone (PEKK) and polyetherketone (PEK), carbon-PEEKcomposites, PEEK-BaSO₄ polymeric rubbers, polyethylene terephthalate(PET), fabric, silicone, polyurethane, silicone-polyurethane copolymers,polymeric rubbers, polyolefin rubbers, hydrogels, semi-rigid and rigidmaterials, elastomers, rubbers, thermoplastic elastomers, thermosetelastomers, elastomeric composites, rigid polymers includingpolyphenylene, polyamide, polyimide, polyetherimide, polyethylene,epoxy, bone material including autograft, allograft, xenograft ortransgenic cortical and/or corticocancellous bone, and tissue growth ordifferentiation factors, partially resorbable materials, such as, forexample, composites of metals and calcium-based ceramics, composites ofPEEK and calcium based ceramics, composites of PEEK with resorbablepolymers, totally resorbable materials, such as, for example, calciumbased ceramics such as calcium phosphate, tri-calcium phosphate (TCP),hydroxyapatite (HA)-TCP, calcium sulfate, or other resorbable polymerssuch as polyaetide, polyglycolide, polytyrosine carbonate,polycaroplaetohe and their combinations.

The components of surgical system 10, individually or collectively, mayalso be fabricated from a heterogeneous material such as a combinationof two or more of the above-described materials. The components ofsurgical system 10 may be monolithically formed, integrally connected orinclude fastening elements and/or instruments, as described herein.

Surgical system 10 can be employed, for example, with a minimallyinvasive procedure, including percutaneous techniques, mini-open andopen surgical techniques to manipulate tissue, deliver and introduceinstrumentation and/or components of spinal constructs at a surgicalsite within a body of a patient, for example, a section of a spine. Insome embodiments, one or more of the components of surgical system 10are configured for engagement with one or more components of one or morespinal constructs, which may include spinal implants, for example,interbody devices, interbody cages, bone fasteners, spinal rods,tethers, connectors, plates and/or bone graft, and can be employed withvarious surgical procedures including surgical treatment of a cervical,thoracic, lumbar and/or sacral region of a spine. In some embodiments,the spinal constructs can be attached with vertebrae in a revisionsurgery to manipulate tissue and/or correct a spinal disorder, asdescribed herein.

Surgical system 10 is employed in an operating room to assist a surgeonin effectively implementing and executing a surgical procedure. Surgicalsystem 10 utilizes a mixed reality and/or augmented reality display, forexample, to holographically overlay digital surgical plans specific to apatient onto a surface of the patient to function as a guide for thesurgeon for implementation of the surgical procedure. In someembodiments, surgical system 10 enables the surgeon to reconcile thesurgical procedure post-operatively by providing a visual comparison ofthe end result of the surgical procedure via a holographic overlay thatis compared to the digital surgical plan holographic overlay.

Surgical system 10 includes a mixed reality display, for example, astereoscopic optical see-through headset 12, as shown in FIG. 2 .Headset 12 is configured to communicate with a database 14 loaded on acomputer 42 that transmits data points of pre-operative imaging 16 of aselected portion of a patient's anatomy, for example, vertebral tissueto headset 12 such that pre-operative imaging 16 can be outputted fromheadset 12. Computer 42 utilizes the data points of pre-operativeimaging 16 to generate images of surgical treatments, surgicalstrategies and surgical plans to be displayed on headset 12. Headset 12is configured to display a surgical treatment configuration image 18 forthe vertebral tissue, a surgical strategy image 20 for implementing thesurgical treatment with the vertebral tissue and intra-operativelydisplaying a surgical plan image 22 for implementing the surgical planwith the vertebral tissue in a common coordinate system. See, forexample, the embodiments and disclosure of systems and methods ofcomponents of a headset, shown and described in commonly owned andassigned U.S. patent application Ser. No. 16/867,812 filed May 6, 2020,and published as U.S. patent application Publication No. US20210346093,on Nov. 11, 2021, the entire contents of which being incorporated hereinby reference.

Surgical treatment image 18 includes a segmentation of the vertebraltissue and/or a surgical reconstruction of the vertebral tissue, asshown in FIG. 6 . Surgical strategy image 20 includes a holographicoverlay of the patient's spine rendered from pre-operative imaging 16,as shown in FIG. 6 . In some embodiments surgical strategy image 20includes a holographic overlay of one or more spinal implants on asurgical reconstruction of the vertebral tissue. Surgical plan image 22includes a holographic overlay having indicia on the vertebral tissue,as shown in FIG. 8 . The indicia represents one or more anatomical zoneson the vertebral tissue.

Headset 12 includes a processor 24, for example, a central processingunit (CPU). Processor 24 is configured to execute one or moreinstructions, for example, software instructions in operation of headset12, as described herein. Processor 24 functions as the primarycoordinating component of headset 12 and is configured to accessprograms, data, and/or other functions from random access memory (RAM)when called by an operating system (OS) of headset 12. Processor 24interprets instructions that are related to ordered tasks before sendingit back to the RAM for execution via a bus of headset 12 in the correctorder of execution.

Headset 12 includes a rendering processor, for example, a graphicsprocessor 25. Graphics processor 25 includes a graphics processing unit(GPU). Graphics processor 25 is configured to render images, animationsand/or video for display on headset 12. In some embodiments, processor24 instructs graphics processor 25 to render the images, animationsand/or video. Images rendered include, for example, surgical treatmentconfiguration image 18, surgical strategy image 20 and/or surgical planimage 22. Graphics processor 25 is configured to communicate with acamera 26 of headset 12 which captures a digital video image of the realworld and transfers the digital video image to graphics processor 25 inreal-time. Graphics processor 25 combines the video image feed withcomputer-generated images (e.g., virtual content), for example, surgicaltreatment configuration image 18, surgical strategy image 20 and/orsurgical plan image 22 and displays the images on headset 12. In someembodiments, headset 12 alternatively or in addition to graphicsprocessor 25 includes a holographic processor 27. Holographic processor27, for example a holographic processing unit (HPU) is configured toconduct the processing that integrates digital video image data of thereal world, data for augmented reality and/or user input (see, forexample, the holographic processing unit sold by Microsoft Corporation,having a place of business in Redmond, Wash., USA).

Headset 12 includes camera 26, for example, a stereoscopic camera, forexample, a pair of cameras. Camera 26 is disposed on a front side 29 ofheadset 12, as shown in FIG. 2 . Camera 26 is configured to capturereal-time digital stereoscopic video images of the patient, for example,the vertebral tissue and/or real-time images of an external environmentof the real world, for example, the operating room during the surgicalprocedure. The real-time images captured by camera 26 are outputted toheadset 12 and displayed on a lens 30 of headset 12. The real-timeimages captured by camera 26 and the surgical plan image 22 renderedfrom graphics processor 25 are displayed concurrently andintra-operatively. In some embodiments, camera 26 includes a depthsensing camera and/or an environment camera. In some embodiments, thedepth sensing camera can work in tandem with the environment camera. Insome embodiments, the depth sensing camera includes infrared, laser,and/or RGB cameras.

Headset 12 includes a sensor 28. Sensor 28 is disposed on front side 29of headset 12. Sensor 28 includes a 3D scanner 32 configured todetermine and capture a 3D surface image 34, for example, the vertebraltissue of the patient, as shown in FIG. 8 so that, for example, surgicalplan image 22 and/or other images can be holographically overlaid ontothe patient through headset 12. In some embodiments, camera 26 alongwith simultaneous localization and mapping implemented by 3D scanner 32digitizes the patient, spinal anatomy, and/or the operating room forspatially locating holograms and then displays the digital informationvia lens 30 of headset 12. Digital video (e.g., stereoscopic video)combined with 3D surface image 34 determined by 3D scanner 32 andpre-operative imaging 16 is combined by graphics processor 25 fordisplay.

In some embodiments, 3D scanner 32 implements simultaneous localizationand mapping (SLAM) technology to determine 3D surface image 34. SLAMtechnology simultaneously localizes (finds the location of anobject/sensor with reference to its surroundings) and maps the layoutand framework of the environment for headset 12. This can be done usinga range of algorithms that simultaneously localize and map the objects.

In some embodiments, 3D surface image 34 of the vertebral tissue can bedetermined through the use of 3D scanner 32, camera 26 and recognitionmarkers (not shown) positioned relative to the patient and/or on asurface of the patient to map the surface of the patient. In someembodiments, the recognition markers may be attached to the patient toprovide anatomic landmarks of the patient during the 3D scanningprocess. The recognition markers, alone or in combination with othertracking devices, such as inertial measurement units (IMU), may beattached to 3D scanner 32, camera 26, and/or the surgeon (e.g. throughheadset 12).

In some embodiments, 3D surface image 34 of the vertebral tissue can bedetermined through the use of 3D scanner 32, camera 26, and/or forexample, spatial transducers, for example, electromagnetic, low energyBluetooth®, and/or inertial measurement units; optical markers, forexample, reflective spheres, QR codes/patterns, and/or fiducials; and/orobject recognition software algorithms to track a spatial position of apatient, for example, a patient's vertebral tissue, for example,vertebral bodies and update a digital representation in real time.

In some embodiments, headset 12 includes sensor 28, motion sensors,acoustic/audio sensors (where the audio is transmitted to speakers (notshown) on headset 12), laser rangefinders, and/or visual sensors. Insome embodiments, headset 12 includes sensor 28 and additional sensorsincluding accelerometers, magnetometers, and/or gyroscopes which measuremotion and direction in space of headset 12 and enables translationalmovement of headset 12 in an augmented environment.

3D surface image 34 is registered via processor 24 functioning as aregistration processor. In some embodiments, processor 24 registers 3Dsurface image 34 and a graphical representation of pre-operative imaging16. In some embodiments, the registered images can be uploaded to acomputer 42, as described herein, external to headset 12. The registered3D surface image 34 will be automatically blended with the registeredgraphical representation of pre-operative imaging 16. The registeredimages can be displayed on headset 12 and/or can be projected over thepatient as a holographic overlay.

Lens 30 includes a screen that employs holographic display technology,for example, optical waveguides to display holograms, image guidance,and/or other digital information in real-time. In some embodiments,headset 12 via lens 30 displays a 360° view through the patient ofpre-operative imaging 16, surgical treatment configuration image 18,surgical strategy 20 image and/or surgical plan image 22. In someembodiments, headset 12 includes, for example, goggles or glasses (see,for example, similar goggles or glasses of HoloLens® or HoloLens® 2(Microsoft Corporation, Redmond, Wash., USA); or Magic Leap® (MagicLeap, Inc, Florida, USA) and/or DreamGlass® (Dreamworld, California,USA)).

In some embodiments, headset 12 employs holographic display technologywhere light particles (e.g., photons) bounce around in a light enginewithin the device. The light particles enter through two lenses 30 ofthe headset 12 where the light particles ricochet between layers ofblue, green and red glass before reaching the back of the surgeon'seyes. Holographic images form when the light is at a specific angle. Insome embodiments, headset 12 includes a contact lens and/or an eye loop.In some embodiments, headset 12 includes a handheld device including,for example, a tablet or a smartphone. In some embodiments, system 10includes projector technology including a display plate as analternative to headset 12 or in addition to headset 12.

As described herein, database 14 transmits data points of pre-operativeimaging 16, surgical treatment configuration image 18, surgical strategy20 image and/or surgical plan image 22 to headset 12 for display. Insome embodiments, database 14 transmits data points of pre-operativeimaging 16 to headset 12 so that headset 12 can generate surgicaltreatment configuration image 18, surgical strategy 20 image andsurgical plan image 22. In some embodiments, the data points ofpre-operative imaging 16 can be transmitted wirelessly or uploaded intoheadset 12.

Pre-operative imaging 16 is generated by an imaging device 36, as shownin FIG. 3 . Imaging device 36 is configured to generate pre-operative,intra-operative and/or post-operative images of a selected portion ofthe patient's anatomy, for example, the vertebral tissue. In someembodiments, imaging device 36 is configured to generate two dimensional(2D) and/or three dimensional (3D) images. In some embodiments, imagingdevice 36 includes, for example, a CT scan. In some embodiments, imagingdevice 36 includes an MR scan, ultrasound, positron emission tomography(PET), and/or C-arm cone-beam computed tomography. Pre-operative imaging16 is then converted into image data to store within database 14. Insome embodiments, pre-operative imaging 16 is converted into image databy a software program.

Database 14 is stored on a tangible storage device 38 that includescomputer-readable instructions. In some embodiments, storage device 38includes a hard drive of computer 42. In some embodiments, storagedevice 38 is an external hard drive unit. In some embodiments, storagedevice 38 includes a magnetic storage device, for example, a floppydiskette, magnetic strip, SuperDisk, tape cassette, or zip diskette; anoptical storage device, for example, a Blu-ray disc, CD-ROM disc, CD-ftCD-RW disc, DVD-R, DVD+R, DVD-RW, or DVD+RW disc; and/or flash memorydevices, for example, USB flash drive, jump drive, or thumb drive,CompactFlash (CF), M.2, memory card, MMC, NVMe, SDHC Card, SmartMediaCard, Sony Memory Stick, SD card, SSD or xD-Picture Card. In someembodiments, storage device 38 includes online storage, cloud storage,and/or network media storage. In some embodiments, headset 12 can accessdatabase 14/storage device 38 wirelessly. In some embodiments, specificdata from database 14 can be uploaded to headset 12, such asintraoperative imaging 16 data, for display.

As shown in FIG. 4 , processor 24 and/or a processor 44, for example, aCPU of computer 42 execute the instructions in operation of system 10.Processor 24 and/or processor 44 execute instructions forpre-operatively imaging 16, displaying surgical treatment configurationimage 18 for the vertebral tissue from headset 12 and/or surgicalstrategy image 20 for implementing the surgical treatment configurationwith the vertebral tissue from headset 12, determining the surgical planfor implementing the surgical strategy, and intra-operatively displayingsurgical plan image 22 with the vertebral tissue from headset 12.

Computer 42 generates surgical treatment image 18, surgical strategyimage 20 and surgical plan image 22, as shown in FIGS. 6 and 8 via asoftware program. In some embodiments, the software program includes,for example, Mazor X™, Mazor X™ Align, and/or Stealthstation™ sold byMedtronic Navigation, Inc. having a place of business in Louisville,Colo. In some embodiments, the software program is 3D image processingsoftware that includes software algorithms employed for the procedureplanning including for example, software algorithms for importing,thresholding, masking, segmentation, cropping, clipping, panning,zooming, rotating, measuring and/or registering. The software program ispreloaded onto computer 42, the surgical strategies and plans aregenerated by the software program, the surgical strategies and plans areuploaded onto headset 12 and graphics processor 25 renders the images sothat the images are outputted from lens 30 for display. In someembodiments, the software program is alternatively preloaded ontoheadset 12, the strategies and plans are generated from the software andheadset 12 displays the strategies and plans from lens 30.

In some embodiments, headset 12 implements software algorithms, forexample, object recognition software algorithms for spatially locatingholograms and displaying the digital information, for example, theholographic overlays. In some embodiments, machine learning algorithmsare employed that identify patient anatomical features, instrumentfeatures and/or implant features for spatially locating holograms anddisplaying digital information.

In some embodiments, headset 12 implements software and/or surgical planimage 22 indicates and/or alerts the surgeon, of danger zones located onan anatomy, for example, the vertebral tissue of the patient to assistthe surgeon in planning the surgical procedure. In some embodiments,danger zones include, spinal nerves, for example, C1 to C8, T1-T12,L1-L5, S1 to S5 and/or the coccyxgeal nerve. In some embodiments, adanger zone includes the posterior triangle of the neck, including thegreat auricular, lesser occipital, spinal accessory, supraclavicular,phrenic, and suprascapular nerves. In some embodiments, danger zonesinclude areas to avoid so that the likelihood of a dura tear is reducedincluding the caudal margin of the cranial lamina, cranial margin of thecaudal lamina, herniated disc level, and medial aspect of the facetjoint adjacent to the insertion of the hypertrophic ligamentum flavum.In some embodiments, surgical plan image 22 and/or the softwaregenerates a warning to the surgeon if a surgical instrument, forexample, a drill or a screw is about to enter into a danger zone or adangerous area. In some embodiments, the alerts, alarms and/or warningsinclude human readable visual indicia, for example, a label, colorcoding, numbers or an icon, human readable tactile indicia, for example,raised portions, dimples and/or texturing, and/or human detectableaudible indicia.

In some embodiments, headset 12 implements software and/or surgical planimage 22 enables a surgeon to select specific locations, for example,critical bone faces on anatomical areas of the patient such that analarm or a warning is generated when the specific locations are indanger of being breached. In some embodiments, headset 12 is configuredto auto-recognize the specific locations.

An image guidance system 46 is provided, as shown in FIGS. 1 and 7 .Headset 12 and/or computer 42 is configured to transfer data, forexample, preoperative imaging 16, surgical treatment image 18, surgicalstrategy image 20 and/or surgical plan image 22 to image guidance system46. Image guidance system 46 includes a tracking device 48 having asensor, for example a sensor array 50 that communicates a signalrepresentative of a position of an image guide 52 connected with asurgical instrument 54 or a spinal implant 56 relative to the vertebraltissue. In some embodiments, one or more image guides 52 can beimplemented. In some embodiments, one or more surgical instruments 54and/or one or more spinal implants 56 can include image guide 52 and beimplemented in image guidance system 46. In some embodiments, surgicalinstrument 54 may include, for example, a driver, extender, reducer,spreader, blade, forcep, elevator, drill, cutter, cannula, osteotome,inserter, compressor and/or distractor.

Tracking device 48 is configured to track a location and orientation ofheadset 12 in the common coordinate system. Tracking device 48 isconfigured to communicate with a processor of image guidance system 46to generate a storable image of surgical instrument 54 and/or spinalimplant 56 relative to the vertebral tissue for display from headset 12,as shown in FIG. 1 . In some embodiments, the processor is processor 44of computer 42. The storable images of surgical instrument 54 and/orspinal implant 56 can be selected intra-operatively and displayed onheadset 12 with surgical plan 22.

In some embodiments, image guide 52 includes for example, fiducials 60.In some embodiments, fiducials 60 include at least one light emittingdiode. In some embodiments, image guide 52 may include other devicescapable of being tracked by sensor array 50, for example, a device thatactively generates acoustic signals, magnetic signals, electromagneticsignals, radiologic signals. In some embodiments, image guide 52includes human readable visual indicia, human readable tactile indicia,human readable audible indicia, one or more components having markersfor identification under x-ray, fluoroscopy, CT or other imagingtechniques, a wireless component, a wired component, and/or a near fieldcommunication component. In some embodiments, image guide 52 may beremovably attached to a navigation component/instrument tracking device,for example, an emitter array 62 attached to surgical instrument 54and/or spinal implant 56, as shown in FIG. 1 . In some embodiments, oneor more image guides 52 each include a single ball-shaped marker.

Image guidance system 46 is connected with a robotic guidance system 64having a surgical guide, for example an end effector 66 connected to arobotic arm R, as shown in FIGS. 1 and 7 . Data from image guidancesystem 46 and robotic guidance system 64 is configured for transmissionto headset 12. During the surgical procedure, headset 12 is configuredto display surgical plan image 22 on the surface of the patient whilecamera 26 of headset 12 provides real-time images of the patient, asshown in FIGS. 1 and 8 . During the surgical procedure, headset 12displays the storable image of surgical instrument 54 and/or spinalimplant 56 and robotic guidance system 64 will assist the surgeon inexecuting the procedure by operating, delivering and/or introducingsurgical instrument 54 and/or spinal implant 56.

Surgical robotic guidance system 64 is employed with surgical instrument54 and/or spinal implant 56 for manipulating vertebral tissue, and fordelivering and introducing spinal implant 56 for engagement with thevertebral tissue. Robotic arm R includes position sensors (not shown),which measure, sample, capture and/or identify positional data points ofend effector 66 in three dimensional space for a guide-wirelessinsertion of spinal implant 56 with the vertebral tissue. In someembodiments, the position sensors of robotic arm R are employed inconnection with a surgical navigation system 68, as shown in FIG. 1 , tomeasure, sample, capture and/or identify positional data points of endeffector 66 in connection with the surgical procedure, as describedherein. The position sensors are mounted with robotic arm R andcalibrated to measure positional data points of end effector 66 in threedimensional space, which are communicated to computer 42.

Surgical instrument 54 is configured for disposal adjacent a surgicalsite such that navigation component, for example, emitter array 62 isoriented relative to sensor array 50 to facilitate communication betweenemitter array 62 and sensor array 50 during the surgical procedure, asdescribed herein. Emitter array 62 is configured to generate a signalrepresentative of a position of spinal implant 56 relative to surgicalinstrument 54 and/or vertebral tissue. In some embodiments, emitterarray 62 is connected with surgical instrument 54 via an integralconnection, friction fit, pressure fit, interlocking engagement, matingengagement, dovetail connection, clips, barbs, tongue in groove,threaded, magnetic, key/keyslot and/or drill chuck.

Emitter array 62 is configured for generating a signal to sensor array50 of surgical navigation system 68, as shown in FIG. 1 and describedherein. In some embodiments, the signal generated by emitter array 62represents a position of spinal implant 56 relative to surgicalinstrument 54 and relative to vertebral tissue. In some embodiments, thesignal generated by emitter array 62 represents a three dimensionalposition of spinal implant 56 relative to the vertebral tissue.

In some embodiments, sensor array 50 receives signals from emitter array62 to provide a three-dimensional spatial position and/or a trajectoryof spinal implant 56 relative to surgical instrument 54 and/or thevertebral tissue. Emitter array 62 communicates with 44 processor ofcomputer 42 of surgical navigation system 68 to generate data fordisplay of an image on a monitor 70, as described herein. In someembodiments, sensor array 50 receives signals from emitter array 62 toprovide a visual representation of a position of spinal implant 56relative to surgical instrument 54 and/or the vertebral tissue. See, forexample, similar surgical navigation components and their use asdescribed in U.S. Pat. Nos. 6,021,343, 6,725,080, 6,796,988, the entirecontents of each of these references being incorporated by referenceherein.

Surgical navigation system 68 is configured for acquiring and displayingmedical imaging, for example, pre-operative image 16 and/or surgicalplan image 22 appropriate for a given surgical procedure. In someembodiments, pre-operative image 16 of a patient is collected, asdescribed above. In some embodiments, surgical navigation system 68 caninclude imaging device 36, as described above. In some embodiments,imaging device 36 is an O-arm® imaging device sold by MedtronicNavigation, Inc. having a place of business in Louisville, Colo., USA.Imaging device 36 may have a generally annular gantry housing thatencloses an image capturing portion 72.

In some embodiments, image capturing portion 72 may include an x-raysource or emission portion and an x-ray receiving or image receivingportion located generally or as practically possible 180 degrees fromeach other and mounted on a rotor (not shown) relative to a track ofimage capturing portion 72. Image capturing portion 72 can be operableto rotate 360 degrees during image acquisition. Image capturing portion72 may rotate around a central point or axis, allowing image data of thepatient to be acquired from multiple directions or in multiple planes.Surgical navigation system 68 can include those disclosed in U.S. Pat.Nos. 8,842,893, 7,188,998; 7,108,421; 7,106,825; 7,001,045; and6,940,941; the entire contents of each of these references beingincorporated by reference herein.

In some embodiments, surgical navigation system 68 can include C-armfluoroscopic imaging systems, which can generate three-dimensional viewsof a patient. The position of image capturing portion 72 can beprecisely known relative to any other portion of an imaging device ofnavigation system 68. In some embodiments, a precise knowledge of theposition of image capturing portion 72 can be used in conjunction withimage guidance system 46 to determine the position of image capturingportion 72 and the image data relative to the patient.

Image guidance system 46 can include various portions that areassociated or included with surgical navigation system 68. In someembodiments, image guidance system 46 can also include a plurality oftypes of tracking systems, for example, an optical tracking system thatincludes an optical localizer, for example, sensor array 50 and/or an EMtracking system that can include an EM localizer. Various trackingdevices can be tracked with image guidance system 46 and the informationcan be used by surgical navigation system 68 to allow for a display of aposition of an item, for example, a patient tracking device, trackingdevice 48, and an instrument tracking device, for example, emitter array62, to allow selected portions to be tracked relative to one anotherwith the appropriate tracking system.

In some embodiments, the EM tracking system can include theSTEALTHSTATION® AXIEM™ Navigation System, sold by Medtronic Navigation,Inc. having a place of business in Louisville, Colo. Exemplary trackingsystems are also disclosed in U.S. Pat. Nos. 8,057,407, 5,913,820,5,592,939, the entire contents of each of these references beingincorporated by reference herein.

In some embodiments, surgical navigation system 68 provides forreal-time tracking of the position of spinal implant 56 relative tosurgical instrument 54 and/or tissue for example, the vertebral tissuecan be tracked. Sensor array 50 is located in such a manner to provide aclear line of sight with emitter array 62, as described herein. In someembodiments, fiducial markers 60 of emitter array 62 communicate withsensor array 50 via infrared technology. Sensor array 50 is coupled tocomputer 42, which may be programmed with software modules that analyzesignals transmitted by sensor array 50 to determine the position of eachobject in a detector space.

As described above, system 10 allows a practitioner the ability toreconcile the surgical procedure post-operatively. After the surgicalprocedure has been completed, intra-operative image 74 or post-operativeimage of surgically treated vertebral tissue is generated by imagingdevice 36. Intra-operative image 74 is converted into image data tostore within database 14. Computer 42 generates an image 76 thatcompares surgical plan image 22 and intra-operative image 74 of thesurgically treated vertebral tissue via the software program describedabove. Image 76 includes a holographic reconciliation overlay of thesurgical plan to the surgically treated vertebral tissue. Image 76 isuploaded to headset 12 for display so that the outcome of the surgicalprocedure can be compared to the surgical plan and reconciled ifrequired.

Processor 24 and/or processor 44 execute instructions in operation ofsystem 10 for reconciliation of the surgical procedure. As shown in FIG.5 , processor 24 and/or processor 44 execute instructions forpre-operatively imaging 16 vertebral tissue; transmitting data points ofthe imaging to computer database 14 and determining a surgical treatmentconfiguration for the vertebral tissue; determining a surgical strategyfor implementing the surgical treatment configuration; generating datapoints representative of surgical treatment configuration image 18 andsurgical strategy image 20; displaying the surgical treatmentconfiguration image 18 and/or the surgical strategy image 20 fromheadset 12; determining a surgical plan for implementing the surgicalstrategy with the vertebral tissue and generating data pointsrepresentative of surgical plan image 22; displaying surgical plan image22 with the vertebral tissue from headset 12; imaging 74 surgicallytreated vertebral tissue; generating data points representative of image76 comparing surgical plan image 22 and imaging 74 of the surgicallytreated vertebral tissue; and displaying image 76 from headset 12.

In assembly, operation and use, surgical system 10, similar to thesystems and methods described herein, is employed with a surgicalprocedure, for treatment of a spine of a patient including vertebrae.Surgical system 10 may also be employed with surgical procedures, suchas, for example, discectomy, laminectomy, fusion, laminotomy,laminectomy, nerve root retraction, foramenotomy, facetectomy,decompression, spinal nucleus or disc replacement and bone graft andimplantable prosthetics including plates, rods, and bone engagingfasteners.

In one embodiment, surgical system 10, similar to the components of thesystems and methods described herein, is employed in connection with oneor more surgical procedures. In some embodiments, system 10 includes amethod 100 for surgically treating a spine, as shown in FIG. 12 . In astep 102, vertebral tissue of a patient is pre-operatively imaged togenerate pre-operative image 16. The vertebral tissue is pre-operativelyimaged via an imaging device 36. In some embodiments, imaging device 36includes a CT scan. In an optional step 104, pre-operative imaging ofthe vertebral tissue is converted to data points and the data points aretransmitted to computer database 14. In some embodiments, the datapoints are converted by a software program, as described above. Computerdatabase 14 is located on computer 42. In a step 106, an image of asurgical treatment configuration, for example, surgical treatmentconfiguration image 18 for the vertebral tissue is displayed from amixed reality display and/or an image of a surgical strategy, forexample, surgical strategy image 20 for implementing the surgicaltreatment configuration with the vertebral tissue is displayed from themixed reality display. The mixed reality display includes headset 12. Insome embodiments, the mixed reality display includes a handheld device.

In some embodiments, surgical treatment configuration image 18 includesa segmentation of the vertebral tissue and/or a surgical reconstructionof the vertebral tissue. In some embodiments, surgical strategy image 20includes a holographic overlay. In some embodiments, surgical strategyimage 20 includes a holographic overlay of one or more spinal implantson a surgical reconstruction of the vertebral tissue. In an optionalstep 108, the surgical treatment configuration for the vertebral tissueand the surgical strategy for implementing the surgical treatmentconfiguration is determined. In some embodiments, surgical treatmentconfiguration image 18 and surgical strategy image 20 are determinedand/or generated from a software program, as disclosed above, including,for example, Mazor X™, Mazor X™ Align, and/or Stealthstation™. In anoptional step 110, data points representative of the images aregenerated.

In a step 112, a surgical plan for implementing the surgical strategy isdetermined. The surgical plan is determined and/or generated from thesoftware described herein. In a step 114, an image of the surgical planwith the vertebral tissue, for example, surgical plan image 22 isintra-operatively displayed from headset 12. In some embodiments,surgical plan image 22 includes a holographic overlay having indicia onthe vertebral tissue. In some embodiments, the indicia represent one ormore anatomical zones.

In some embodiments, image guidance system 46 and/or robotic guidancesystem 64, described herein with regard to system 10 are employed withmethod 100. Data from image guidance system 46 and robotic guidancesystem 64 is configured for transmission to headset 12. During thesurgical procedure, headset 12 is configured to display surgical planimage 22 on the surface of the patient while camera 26 of headset 12provides real-time images of the patient, as shown in FIGS. 1 and 8 .During the surgical procedure, headset 12 displays the storable image ofsurgical instrument 54 and/or spinal implant 56 and robotic guidancesystem 64 will assist the surgeon in executing the procedure byoperating, delivering and/or introducing surgical instrument 54 and/orspinal implant 56.

In an optional step 116, surgically treated vertebral tissue is imaged,for example, including intra-operative image 74 and/or a post-operativeimage. Intra-operative image 74 and/or the post-operative image aregenerated by imaging device 36. In some embodiments, the step of imagingsurgically treated vertebral tissue includes an intra-operative CT scanand/or a post-operative CT scan. In an optional step 118, an image 76comparing surgical plan image 22 and intra-operative image 74 and/orpost-operative image is displayed from headset 12. In some embodiments,the step of displaying image 76 includes a holographic reconciliationoverlay of the surgical strategy and/or plan to the surgically treatedvertebral tissue. Image 76 is determined and/or generated from softwaredescribed herein.

In some embodiments, system 10 includes a method 200 for surgicallytreating a spine, as shown in FIG. 13 , similar to method 100, as shownin FIG. 12 . In a step 202, vertebral tissue is pre-operatively imagedto generate pre-operative image 16. In a step 204, an image of asegmentation and a surgical reconstruction of the vertebral tissue, forexample, surgical treatment configuration image 18 is displayed from aholographic display and/or an image of a surgical strategy that includesone or more spinal implants with the vertebral tissue, for example,surgical strategy image 20 is displayed from headset 12. In a step 206,a surgical plan for implementing the surgical strategy is determined.

In a step 208, an image of the surgical plan with the vertebral tissue,for example, surgical plan image 22 is intra-operatively displayed fromheadset 12. In an optional step 210, surgically treated vertebral tissueis imaged, for example, including intra-operative image 74 and/or apost-operative image. In an optional step 212, an image 76 comparingsurgical plan image 22 and intra-operative image 74 is displayed fromthe holographic display. In some embodiments, the step of displayingimage 76 includes a holographic reconciliation overlay of the surgicalstrategy and/or surgical plan to the surgically treated vertebraltissue. In some embodiments, surgical plan image 22 includes aholographic overlay having indicia on the vertebral tissue, the indiciarepresenting one or more anatomical zones.

In some embodiments, system 10 includes a method 300 for surgicallytreating a spine, as shown in FIG. 14 , similar to method 100, as shownin FIG. 12 and method 200, as shown in FIG. 13 . In a step 302,vertebral tissue is pre-operatively imaged to generate pre-operativeimage 16. In step 304, data points of the imaging are transmitted to acomputer database 14. In a step 306, a surgical treatment configurationfor the vertebral tissue is determined. In a step 308, a surgicalstrategy for implementing the surgical treatment configuration isdetermined. In a step 310, data points representative of an image of thesurgical treatment configuration, for example, surgical treatmentconfiguration image 18 and an image of the surgical strategy, forexample, surgical strategy image 20 are generated. In a step 312,surgical treatment configuration image 18 and/or surgical strategy image20 is displayed from headset 12. In a step 314, a surgical plan forimplementing the surgical strategy with the vertebral tissue isdetermined. In a step 316, data points representative of an image of thesurgical plan, for example, surgical plan image 22 is generated. In astep 318, surgical plan image 22 is displayed from headset 12.

In a step 320, surgically treated vertebral tissue is imaged, forexample, including intra-operative image 74 and/or a post-operativeimage. In a step 322, data points representative of an image 76comparing surgical plan image 22 and intra-operative image 74 aregenerated. In a step 324, image 76 is displayed from headset 12. In someembodiments, the step of displaying image 76 includes a holographicreconciliation overlay of the surgical strategy to the surgicallytreated vertebral tissue. In some embodiments, surgical plan image 22includes a holographic overlay having indicia on the vertebral tissue,the indicia representing one or more anatomical zones.

In some embodiments, headset 12 implements software and/or surgical planimage 22 of methods 100, 200 and/or 300 indicates and/or alerts thesurgeon, of danger zones located on an anatomy, for example, thevertebral tissue of the patient to assist the surgeon in planning thesurgical procedure in the methods described above. In some embodiments,the surgical plan image 22 and/or the software generates a warning tothe surgeon if a surgical instrument, for example, a drill or a screw isabout to enter into a danger zone or a dangerous area.

In some embodiments, headset 12 implements software and/or surgical planimage 22 enables a surgeon to select specific locations, for example,critical bone faces on anatomical areas of the patient such that analarm or a warning is generated when the specific locations are indanger of being breached. In some embodiments, headset 12 is configuredto auto-recognize the specific locations.

It will be understood that various modifications may be made to theembodiments disclosed herein. Therefore, the above description shouldnot be construed as limiting, but merely as exemplification of thevarious embodiments. Those skilled in the art will envision othermodifications within the scope and spirit of the claims appended hereto.

What is claimed is:
 1. A method for surgically treating a spine, themethod comprising the steps of: pre-operatively imaging vertebraltissue; displaying a first image of a surgical treatment configurationfor the vertebral tissue from a mixed reality display and/or a secondimage of a surgical strategy for implementing the surgical treatmentconfiguration with the vertebral tissue from the mixed reality display;determining a surgical plan including robotic guidance for implementingthe surgical strategy; intra-operatively displaying a third image of thesurgical plan with the vertebral tissue from the mixed reality display;implementing the surgical plan with the robotic guidance; imagingsurgically treated vertebral tissue; and displaying a fourth imagecomparing the third image and the imaging of the surgically treatedvertebral tissue from the mixed reality display.
 2. A method as recitedin claim 1, further comprising the steps of transmitting data points ofthe pre-operative imaging to a computer database; and determining thesurgical treatment configuration for the vertebral tissue and thesurgical strategy for implementing the surgical treatment configuration.3. A method as recited in claim 2, further comprising the steps ofgenerating data points representative of the first image and/or thesecond image.
 4. A method as recited in claim 1, wherein the step ofimaging surgically treated vertebral tissue includes an intra-operativeCT scan.
 5. A method as recited in claim 1, wherein the step ofdisplaying the fourth image includes a holographic reconciliationoverlay of the surgical strategy to the surgically treated vertebraltissue.
 6. A method as recited in claim 1, wherein the pre-operativeimaging includes a CT scan.
 7. A method as recited in claim 1, whereinthe mixed reality display includes a headset.
 8. A method as recited inclaim 1, wherein the mixed reality display includes a handheld device.9. A method as recited in claim 1, wherein the second image includes aholographic overlay.
 10. A method as recited in claim 1, wherein thesurgical treatment configuration includes a segmentation of thevertebral tissue and/or a surgical reconstruction of the vertebraltissue.
 11. A method as recited in claim 1, wherein the second imageincludes a holographic overlay of one or more spinal implants on asurgical reconstruction of the vertebral tissue.
 12. A method as recitedin claim 1, wherein the third image includes a holographic overlayhaving indicia on the vertebral tissue, the indicia representing one ormore anatomical zones.
 13. A method for surgically treating a spine, themethod comprising the steps of: pre-operatively imaging vertebraltissue; displaying a first image of a segmentation and a surgicalreconstruction of the vertebral tissue from a holographic display and/ora second image of a surgical strategy that includes one or more spinalimplants with the vertebral tissue from the holographic display;determining a surgical plan including robotic guidance for implementingthe surgical strategy; intra-operatively displaying a third image of thesurgical plan with the vertebral tissue from the holographic display;implementing the surgical plan with the robotic guidance; imagingsurgically treated vertebral tissue; and displaying a fourth imagecomparing the third image and the imaging of the surgically treatedvertebral tissue from the holographic display.
 14. A method as recitedin claim 13, wherein the step of displaying the fourth image includes aholographic reconciliation overlay of the surgical strategy to thesurgically treated vertebral tissue.
 15. A method as recited in claim13, wherein the third image includes a holographic overlay havingindicia on the vertebral tissue, the indicia representing one or moreanatomical zones.
 16. A method for surgically treating a spine, themethod comprising the steps of: pre-operatively imaging vertebraltissue; transmitting data points of the imaging to a computer databaseand determining a surgical treatment configuration for the vertebraltissue; determining a surgical strategy for implementing the surgicaltreatment configuration; generating data points representative of afirst image of the surgical treatment configuration and a second imageof the surgical strategy; displaying the first image and/or the secondimage from a mixed reality display; determining a surgical planincluding robotic guidance for implementing the surgical strategy withthe vertebral tissue and generating data points representative of athird image of the surgical plan; displaying the third image with thevertebral tissue from the mixed reality display; implementing thesurgical plan with the robotic guidance; imaging surgically treatedvertebral tissue; generating data points representative of a fourthimage comparing the third image and the imaging of the surgicallytreated vertebral tissue; and displaying the fourth image from the mixedreality display, the fourth image including a holographic reconciliationoverlay of the surgical strategy to the surgically treated vertebraltissue.
 17. A method as recited in claim 16, wherein the third imageincludes a holographic overlay having indicia on the vertebral tissue,the indicia representing one or more anatomical zones.